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Test |
|
Specification |
| |
Description |
: |
A White to off-white crystalline powder |
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Solubility |
: |
Sparingly soluble in water, soluble in methanol, practically insoluble in Methylene Chloride |
| |
Identification
|
: |
|
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B) By infrared spectrophotometer |
|
The spectrum of Ambroxol hydrochloride is concordant with the spectrum obtained from Ambroxol hydrochloride working standard |
| |
D) Chloride test |
: |
Should respond to chloride test |
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pH (of 1% Solution in water) |
: |
Between 4.50 and 6.00 |
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Related Substances by HPLC
a) Individual major impurity
b) Total impurities |
: |
Not more than 0.5% w/w
Not more than 1.0% w/w |
| |
Loss on Drying |
: |
Not more than 0.50% w/w |
| |
Sulphated Ash |
|
Not more than 0.10% w/w |
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Heavy metals |
: |
Not more than 20 ppm |
| |
Assay (on dried basis) |
: |
Not less than 99.0% and Not more than 101.0% w/w |
| |
Residual Solvents |
|
|
| |
|
|
Not more than 200ppm
Not more than 2500 ppm |
